Product Description And Intended Use; Product Instructions - 3M MDA2CAM96 Mode D'emploi

3
Molecular Detection Assay 2 - Campylobacter

Product Description and Intended Use

The 3M™ Molecular Detection Assay 2 - Campylobacter is used with the 3M™ Molecular Detection System for the rapid
and specific detection of Campylobacter jejuni, Campylobacter lari and Campylobacter coli in enriched foods and food
process environmental samples.
The 3M Molecular Detection Assay uses loop-mediated isothermal amplification to rapidly amplify nucleic acid sequences
with high specificity and sensitivity, combined with bioluminescence to detect the amplification. Presumptive positive
results are reported in real-time while negative results are displayed after the assay is completed. Presumptive positive
results should be confirmed using your preferred method or as specified by local regulations
The 3M Molecular Detection Assay 2 - Campylobacter is intended for use in a laboratory environment by professionals
trained in laboratory techniques. 3M has not documented the use of this product in industries other than food or beverage.
For example, 3M has not documented this product for testing pharmaceutical, cosmetics, clinical or veterinary samples.
The 3M Molecular Detection Assay 2 - Campylobacter has not been evaluated with all possible food products, food
processes, testing protocols or with all possible strains of bacteria.
As with all test methods, the source, formulation and quality of enrichment medium can influence the results. Factors
such as sampling methods, testing protocols, sample preparation, handling, and laboratory technique may also influence
results. 3M recommends evaluation of the method including enrichment medium, in the user's environment using a sufficient
number of samples with particular foods and microbial challenges to ensure that the method meets the user's criteria.
3M has evaluated the 3M Molecular Detection Assay 2 - Campylobacter with the 3M™ Campylobacter Enrichment Broth
and blood-free Bolton Enrichment Broth.
The 3M™ Molecular Detection Instrument is intended for use with samples that have undergone heat treatment during
the assay lysis step, which is designed to destroy organisms present in the sample. Samples that have not been properly
heat treated during the assay lysis step may be considered a potential biohazard and should NOT be inserted into the 3M
Molecular Detection Instrument.
3M Food Safety is certified to ISO (International Organization for Standardization) 9001 for design and manufacturing.
The 3M Molecular Detection Assay 2 - Campylobacter test kit contains 96 tests, described in Table 1.
Table 1. 3M Molecular Detection Assay Kit Components
Item
3M™ Lysis Solution (LS)
3M™ Molecular Detection
Assay 2 - Campylobacter
Reagent Tubes
Extra caps
3M™ Reagent Control (RC)
The Negative Control (NC), not provided in the kit, is a sterile enrichment medium, e.g., 3M Campylobacter Enrichment
Broth. Do not use water as a NC.
A quick start guide is available at www.3M.com/foodsafety
Safety
The user should read, understand and follow all safety information in the instructions for the 3M Molecular Detection
System and the 3M Molecular Detection Assay 2 - Campylobacter. Retain the safety instructions for future reference.
Identification
Pink solution in clear
96 (12 strips of 8 tubes)
tubes
Purple tubes containing 4 strips of
Purple caps 96 (12 strips of 8 caps)
Clear flip-top tubes
1

Product Instructions

Quantity
580 μL of LS per
96 (3 pouches; Lyophilized specific
amplification and
8 tubes)
Lyophilized control
16 (2 pouches of
DNA, amplification
8 individual tubes)
and detection mix
EN (English)
Issue Date: 2019-01
.
(1,2)
Contents Comments
Racked and
tube ready to use
Ready to use
detection mix
Ready to use
Ready to use